JALEX Medical, LLC
Angelica Boucher, CQA, is a Senior Quality and Regulatory Engineer at JALEX Medical, LLC. Angelica has a background in quality engineering, supplier quality, and product development within the medical device industry. With experience in FDA regulations, ISO standards, and regulatory submissions, Angelica plays a key role in accelerating medical device design and development processes. In addition to their professional career, Angelica has also engaged in research projects aimed at predicting ACL injury mechanisms in young female athletes during their undergraduate studies in Bioengineering.
JALEX Medical, LLC
JALEX Medical is a privately held design, engineering, and product development firm headquartered in Westlake, just west of Cleveland, Ohio. Our highly experienced team has helped hundreds of clients bring innovations to market since 2012. With an emphasis on Class I and Class II devices, JALEX offers unrivaled support and expertise in bringing your idea from Concept to Commercialization. Additionally, our team provides a la carte professional support and expertise throughout design, verification, validation, regulatory, and QMS development phases. Every member of JALEX’s medical device consulting team specializes in his or her department but has thorough cross training in all aspects of the medical device development process. As a result, the team brings tremendous value to our clients by providing all the services you need under one roof. Services include: - Medical Device Design - Regulatory Affairs - Quality Management Systems - Project Management - Project Rescue Areas of Expertise: - Cardiology - Dental - ENT - Gastroenterology - General Surgery - Neurological - Ophthalmology - Oral and Maxillofacial - Orthopedics - Pain Management - Pediatrics - Podiatry - Plastic Surgery - Pulmonology - Radiology - Spine - Upper and lower extremity - Urology - Vascular